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Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa

Primary Purpose

HSV-2 Infection, HIV Infections, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
School-based sexuality and HIV prevention scripted lesson plans
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HSV-2 Infection focused on measuring HIV prevention, School-based programming, Pregnancy prevention, South Africa, Genital herpes

Eligibility Criteria

11 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For the main cohort sample - females in grade 8 were enrolled in 2016 and followed for two years. All participating girls had to

  • receive parental consent,
  • provide assent, and
  • give contact information for study linking.

For the cross-sectional samples, female and male learners in grade 8 in 2016; in grade 9 in 2017 and in grade 10 in 2018 were eligible to participate assuming

  • they had parental consent and
  • assented to participate.

Exclusion Criteria:

  • Must understand one of the five languages that the survey was administered in.

Sites / Locations

  • Darryn Durno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Scripted lesson plan life orientation curriculum

Standard life orientation curriculum

Arm Description

Participants in this arm were in schools where the life orientation teachers in grades 7-9 (in 2016 and 2017) and grade 10 in 2018 were trained to use the new life orientation curriculum that included scripted lesson plans for the sexual and reproductive health content of the program. There are eight lessons for grade 7, eight for grade 8, 11 for grade 9, and 10 for grade 10.

Participants in this arm were in schools where the standard life orientation curriculum was used with no additional training and no use of the new materials.

Outcomes

Primary Outcome Measures

Change in HSV-2 experience (Incidence of HSV-2)
Numerator: number of girls in the longitudinal cohort that test positive for genital herpes (HSV-2); Denominator: all cohort girls who did not have HSV-2 at baseline HSV-2 is measured using biomarkers. Dried blood spots were collected at baseline and again and endline. The baseline dried blood spots were stored in freezers until after analysis of the endline dried blood spots. Those who tested positive for genital herpes at endline were tested at baseline to determine if it was a new (incident) infection or if the girl already had genital herpes at baseline. The incidence measure is a change from her earlier status.
Change in pregnancy experience (Pregnancy incidence)
The percentage of girls in the longitudinal cohort who were never pregnant at baseline and who experience a pregnancy (self-reported) by endline. This is measuring a change in her experience with a pregnancy (incidence).
Change in HSV-2 or pregnancy experience (combined outcome)
Percentage of girls in the longitudinal cohort who experience either incident HSV-2 infection or a pregnancy since baseline. This is measuring a change her her status.

Secondary Outcome Measures

Knowledge of HIV risk score
Eight items were measured at each survey round to determine young people's knowledge of how HIV spreads. Each question was posed as a "True," "False," or "Don't know" option. Correct responses were coded one and incorrect or don't know responses were coded zero. Correct responses were summed so that a higher knowledge score indicates greater knowledge about HIV risk.
Gender norm attitudes (based on the Gender Equitable Men Scale)
This was measured at each survey round using 17 items that were designed based on the Gender Equitable Men Scale, with additional items added. All questions were asked on a scale of "Agree a lot" to "Do not agree at all." These were coded as Agree a lot=1 to Do not agree at all =3. All were recoded so that higher values represent more equitable attitudes. We sum up the 17 items so that the summed scale equates to higher values being more equitable attitudes.
Percentage of learners who were tested for HIV in the last 12 months
This was measured at each survey round by asking participants to self report if they visited a facility for an HIV test in the last 12 months. This is used to examine participants experience with HIV testing and if there are changes over time across the study groups.
HIV prevalence
Using dried blood spots collected in the female cross-sectional sample at endline as well as the female cohort, the investigators are able to measure the prevalence of HIV at endline. This was an outcome that was added in the course of the study and was not part of the original protocol.
Self-reported sexual experience - percentage
Measured by self-reported sexual initiation (age of sexual initiation)
Self-reported number of sexual partners, among sexually experienced - percentage
Measured by self-reported number of sexual partners in the last year. This will be categorized once the distribution is examined.
Self-reported condom use, among sexually experienced - percentage
Measured by percentage of learners who self-report that they used a condom at last sex.

Full Information

First Posted
December 17, 2019
Last Updated
December 18, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Pretoria, SADC Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04205721
Brief Title
Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
Official Title
Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2016 (Actual)
Primary Completion Date
November 4, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Pretoria, SADC Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the impact of the new South African Department of Basic Education (DBE) sexuality and HIV education program that uses scripted lesson plans and supporting activities and will be implemented by Education Development Center (EDC). The primary outcomes are the incidence of HSV-2 or pregnancy among a cohort of learners in grade 8 and followed for two years in two provinces of South Africa.
Detailed Description
This evaluation focuses on the HIV and sexual and reproductive health (SRH) content of the Government of South Africa life orientation (LO) Curriculum. In 2010, the Department of Basic Education (DBE) undertook assessments of their LO program and learned that while young people who participated in the program had improved knowledge and attitudes, the program was not being implemented uniformly, such that the results were inconsistent across schools and learners. To address these concerns, DBE, with support from the United States Agency for International Development (USAID) and the United States President's Emergency Plan for AIDS Relief (PEPFAR), developed scripted lesson plans (SLP) to strengthen the SRH content and standardize implementation across schools; these SLP were paired with supporting activities to address fidelity in the curriculum's delivery. The SLP were integrated in the LO program, with most of the lessons offered in the first half of the school year. The lessons were developed for grades 4-6, 7-9, and 10-12. This evaluation focuses on the curricula for grades 7-9 and 10-12. There are eight lessons for grade 7, eight for grade 8, 11 for grade 9, and 10 for grade 10. Notably, there were delays in getting DBE approvals for release of the grade-10 curriculum. A key component of the program is that all LO teachers are trained on the new materials prior to implementation. Since 2015, USAID/PEPFAR has provided technical support to DBE for program roll out in priority provinces and districts that have the highest HIV incidence and prevalence. Technical support includes educator training on the new SLP and considerations of approaches for scale-up beyond the initial districts. Support for the first phase of implementation and testing was led by Education Development Center, with funding from USAID. The goal of the proposed impact evaluation is to assess the impact of the LO program on students over time. The primary evaluation question is: What is the effect of the scripted lesson plans and supporting activities on the incidence of HSV-2 or pregnancy after two years among a cohort of girls enrolled in grade 8 at intervention schools compared to a cohort of girls in grade 8 at control schools providing the current life skills program (i.e., the standard of practice)? The secondary evaluation questions include: What is the effect of the scripted lesson plans and supporting activities on knowledge, attitudes, school retention, and self-reported risk behavior, HIV testing, and completed referrals for health services at the end of 8th, 9th, and 10th grade among a cohort of girls first interviewed in grade 8 and among a cross-section girls and boys interviewed in grade 8, grade 9 and grade 10? If there is a reduction in the primary outcome, does the intervention work by increasing school retention, or is the effect independent of school retention?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HSV-2 Infection, HIV Infections, Pregnancy Related
Keywords
HIV prevention, School-based programming, Pregnancy prevention, South Africa, Genital herpes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized cluster design whereby schools were assigned to intervention or control schools before the trial began.
Masking
Participant
Masking Description
Participants are either in intervention or control schools (intervention schools received the new curriculum); participants did not know about this prior assignment.
Allocation
Randomized
Enrollment
23061 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scripted lesson plan life orientation curriculum
Arm Type
Experimental
Arm Description
Participants in this arm were in schools where the life orientation teachers in grades 7-9 (in 2016 and 2017) and grade 10 in 2018 were trained to use the new life orientation curriculum that included scripted lesson plans for the sexual and reproductive health content of the program. There are eight lessons for grade 7, eight for grade 8, 11 for grade 9, and 10 for grade 10.
Arm Title
Standard life orientation curriculum
Arm Type
No Intervention
Arm Description
Participants in this arm were in schools where the standard life orientation curriculum was used with no additional training and no use of the new materials.
Intervention Type
Behavioral
Intervention Name(s)
School-based sexuality and HIV prevention scripted lesson plans
Intervention Description
The revised life orientation content and implementation approach were designed to address gaps in prior implementation of the sexuality and HIV education content. By using scripted lesson plans and training teachers to use these, it was thought that students would get better information and lessons on the material important for HIV prevention.
Primary Outcome Measure Information:
Title
Change in HSV-2 experience (Incidence of HSV-2)
Description
Numerator: number of girls in the longitudinal cohort that test positive for genital herpes (HSV-2); Denominator: all cohort girls who did not have HSV-2 at baseline HSV-2 is measured using biomarkers. Dried blood spots were collected at baseline and again and endline. The baseline dried blood spots were stored in freezers until after analysis of the endline dried blood spots. Those who tested positive for genital herpes at endline were tested at baseline to determine if it was a new (incident) infection or if the girl already had genital herpes at baseline. The incidence measure is a change from her earlier status.
Time Frame
Baseline and 24 month follow-up
Title
Change in pregnancy experience (Pregnancy incidence)
Description
The percentage of girls in the longitudinal cohort who were never pregnant at baseline and who experience a pregnancy (self-reported) by endline. This is measuring a change in her experience with a pregnancy (incidence).
Time Frame
Baseline, 12 month and 24 month follow-up
Title
Change in HSV-2 or pregnancy experience (combined outcome)
Description
Percentage of girls in the longitudinal cohort who experience either incident HSV-2 infection or a pregnancy since baseline. This is measuring a change her her status.
Time Frame
Baseline and 24 month follow-up
Secondary Outcome Measure Information:
Title
Knowledge of HIV risk score
Description
Eight items were measured at each survey round to determine young people's knowledge of how HIV spreads. Each question was posed as a "True," "False," or "Don't know" option. Correct responses were coded one and incorrect or don't know responses were coded zero. Correct responses were summed so that a higher knowledge score indicates greater knowledge about HIV risk.
Time Frame
Collected at baseline, 12 month and 24 month follow-up
Title
Gender norm attitudes (based on the Gender Equitable Men Scale)
Description
This was measured at each survey round using 17 items that were designed based on the Gender Equitable Men Scale, with additional items added. All questions were asked on a scale of "Agree a lot" to "Do not agree at all." These were coded as Agree a lot=1 to Do not agree at all =3. All were recoded so that higher values represent more equitable attitudes. We sum up the 17 items so that the summed scale equates to higher values being more equitable attitudes.
Time Frame
Collected at baseline, 12 month and 24 month follow-up
Title
Percentage of learners who were tested for HIV in the last 12 months
Description
This was measured at each survey round by asking participants to self report if they visited a facility for an HIV test in the last 12 months. This is used to examine participants experience with HIV testing and if there are changes over time across the study groups.
Time Frame
Collected at baseline, 12 month and 24 month follow-up
Title
HIV prevalence
Description
Using dried blood spots collected in the female cross-sectional sample at endline as well as the female cohort, the investigators are able to measure the prevalence of HIV at endline. This was an outcome that was added in the course of the study and was not part of the original protocol.
Time Frame
24 month follow-up period only
Title
Self-reported sexual experience - percentage
Description
Measured by self-reported sexual initiation (age of sexual initiation)
Time Frame
Collected at baseline, 12 month and 24 month follow-up
Title
Self-reported number of sexual partners, among sexually experienced - percentage
Description
Measured by self-reported number of sexual partners in the last year. This will be categorized once the distribution is examined.
Time Frame
Collected at baseline, 12 month and 24 month follow-up
Title
Self-reported condom use, among sexually experienced - percentage
Description
Measured by percentage of learners who self-report that they used a condom at last sex.
Time Frame
Collected at baseline, 12 month and 24 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For the main cohort sample - females in grade 8 were enrolled in 2016 and followed for two years. All participating girls had to receive parental consent, provide assent, and give contact information for study linking. For the cross-sectional samples, female and male learners in grade 8 in 2016; in grade 9 in 2017 and in grade 10 in 2018 were eligible to participate assuming they had parental consent and assented to participate. Exclusion Criteria: Must understand one of the five languages that the survey was administered in.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilene Speizer, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Darryn Durno
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data are available on a publicly available server: https://dataverse.unc.edu/dataverse/cpc
IPD Sharing Time Frame
Currently available
IPD Sharing Access Criteria
Request through data verse below.
IPD Sharing URL
http://dataverse.unc.edu/dataverse/cpc
Citations:
PubMed Identifier
29688772
Citation
Speizer IS, Mandal M, Xiong K, Hattori A, Makina-Zimalirana N, Kumalo F, Taylor S, Ndlovu MS, Madibane M, Beke A. Methodology and Baseline Results From the Evaluation of a Sexuality Education Activity in Mpumalanga and KwaZulu-Natal, South Africa. AIDS Educ Prev. 2018 Apr;30(2):152-168. doi: 10.1521/aeap.2018.30.2.152.
Results Reference
background
PubMed Identifier
33362883
Citation
Speizer IS, Xiong K, Mandal M, Makina-Zimalirana N, Hattori A, Durno D. HIV-Related Knowledge, Attitudes, and Behaviors among Grade 10 Girls and Boys in Mpumalanga and KwaZulu-Natal: Cross-Sectional Results. Open AIDS J. 2020;14:75-83. doi: 10.2174/1874613602014010075. Epub 2020 Sep 18.
Results Reference
derived
PubMed Identifier
33054742
Citation
Speizer IS, Mandal M, Xiong K, Makina N, Hattori A, Durno D. Impact evaluation of scripted lesson plans for HIV-related content in a life orientation curriculum: results from two provinces in South Africa. BMC Public Health. 2020 Oct 14;20(1):1542. doi: 10.1186/s12889-020-09640-2.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://dataverse.unc.edu/dataverse/cpc
Available IPD/Information Comments
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